MAUDE Adverse Event Report: ATRIUM MEDICAL CORP C-QUR V-PATCH

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

During the (b)(6) conference a report of infection after hernia repair was received.Out of 11 pts one had infection.

Manufacturer Narrative

We are unable to investigate this report as the product code, lot number or sample was available.If further information is obtained a follow up report will be submitted.

• Brand Name: C-QUR V-PATCH
• Manufacturer (Section D): ATRIUM MEDICAL CORP; hudson NH
• Manufacturer Contact: theresa morin, complaints mgr ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3632477
• MDR Text Key: 3991559
• Report Number: 1219977-2014-00009
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K080688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2013
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other